Institutional Review Board (IRB) Policy

Federal regulations protecting human subjects were first enacted in the United States in 1974 with the passage of the National Research Act. The basic ethical principles that continue to undergird all research with human subjects are described in the Belmont Report, released in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. The Belmont Report provides the framework for all federal regulations and policies that guide research with human subjects.

To that end, the University of Nebraska provides a formal guarantee (Federal wide Assurance FWA00015273) to the Office for Human Research Protections (OHRP) that it will follow procedures to assure the protection of all human subjects involved in research projects. This guarantee applies to all human subject research conducted by anyone on the premises of the University of Nebraska (UNMC, UNL, UNO, UNK) and to research conducted elsewhere by faculty, students, staff, or other representatives of the University in connection with their institutional responsibilities.

In order to comply with this assurance, the University of Nebraska has established an institutional committee competent to review research projects that involve human subjects. Under the provisions of the HHS Regulations for Protection of Human Subjects (45 CFR 46), this committee has been designated as the Institutional Review Board (IRB). The IRB consists of representatives from a variety of scientific disciplines as well as community members. The primary function of the IRB is to assist the investigator in the protection of the rights and welfare of human subjects. Investigators, however, carry primary responsibility for assuring that research protocols measure up to standards established by the federal regulations and the IRB. The IRB also serves to facilitate valuable human subject research as well as to protect the investigator and the institution through a comprehensive review process.

INVESTIGATIONAL ACTIVITIES REQUIRING IRB REVIEW AND APPROVAL

Before a human subject research project is initiated it must first be reviewed and approved by the IRB and then conducted in full compliance with the IRB Guidelines. There can be no exceptions to this requirement; violations may result in serious repercussions for the institution. Research requiring IRB review includes investigations conducted by faculty, students, staff or others on the premises of the University of Nebraska as well as investigations conducted elsewhere by any representative of the University of Nebraska in connection with their institutional responsibilities unless the investigation is conducted under a cooperative research agreement as per 45 CFR 46.114. The type of review required depends upon the classification (Full Board, Expedited, Exempt) of the proposal. See the IRB website for details about the level of review.

Research is broadly classified as therapeutic and non-therapeutic. Therapeutic research is an investigation designed to determine the efficacy and safety of a therapeutic or diagnostic method. The interventions are not applied solely to enhance the well being of the individual subject who is sick (note use of the term "subject" as opposed to "patient"). The objective of therapeutic research is to increase generalizable knowledge (i.e., test a hypothesis and draw conclusions) and at the same time provide the subject with a needed health benefit. In contrast to therapeutic research, non-therapeutic research is an investigation that has no intent of producing a diagnostic, preventive, or therapeutic benefit to the subject who is usually healthy and is not seeking nor expecting a health benefit from the research.

At UNK, all researchers including faculty, students, staff, and mentors of student research are required to pass an online training program, called the CITI Course in the Protection of Human Research Subjects. The link to the training course is available on the IRB website. The training course must be completed before the IRB will review research projects.